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Aldeyra Therapeutics Releases Expanded Results from Allergen Chamber Trial and Announces Plans to Initiate the Phase 3 INVIGORATE Trial in Patients with Allergic Conjunctivitis
Highly statistically significant activity relative to vehicle across every assessed symptom and sign observed in allergen chamber clinical trial Agreement
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nHighly statistically significant activity relative to vehicle across every assessed symptom and sign observed in allergen chamber clinical trial\n\n\nAgreement reached with U.S. FDA on design of Phase 3 INVIGORATE trial, expected to initiate in the first half of 2020\n\n\nCompany to host conference call and webcast at 8:00 a.m. ET today\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced expanded results from the company’s allergen chamber clinical methods trial (#NCT03709121) of topical ocular reproxalap in patients with allergic conjunctivitis, and Phase 3 clinical trial plans based on recent feedback from the U.S. Food & Drug Administration (FDA).\n\n\n“The expanded results from our allergen chamber trial demonstrate highly statistically significant activity of reproxalap relative to vehicle across all assessed symptoms and signs,\" commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Based on the positive outcome of the trial, we have reached agreement with the FDA on the design and the primary endpoint for our Phase 3 INVIGORATE trial – statistical significance in ocular itching at a majority of time points over a pre-specified range. Importantly, in the completed allergen chamber trial, all time points to be pre-specified in the INVIGORATE trial were statistically significant.”\n\n\nThe double-masked, randomized, vehicle-controlled, crossover allergen chamber clinical methods trial assessed the efficacy and safety of 0.25% and 0.5% concentrations of reproxalap topical ophthalmic solution compared with vehicle in 70 patients with ocular allergy to ragweed. Patient-reported ocular itching and tearing, and investigator-assessed ocular redness, were recorded at various intervals over approximately 3.5 hours during exposure to a standardized amount of ragweed pollen. Test article was administered before chamber entry and at 90 minutes post-entry, near the peak of allergy symptoms and signs.\n\n\nRelative to patients treated with vehicle, patients treated with 0.25% or 0.5% reproxalap demonstrated statistically significant reduction in ocular itching (p","length":3031,"tagName":"div"}]